FDA asks Pfizer to pull misleading journal ad
Pharma Compliance Alert, August 15, 2007
A journal ad for Pfizer's Geodon for Injection contained unsubstantiated superiority claims and omits risk information, according to a letter from DDMAC that was released in July but posted online this week.
Geodon for Injection's labeling contains a black box warning about potentially fatal adverse reactions to the drug, as well as contraindications and other risk information. Although the journal ad discusses the black box warning, it fails to include other risk information, which makes the drug appear that it's safer than has been shown, according to the FDA.
The journal ad also implies that Geodon for Injection is more effective than another treatment "when this has not been demonstrated by substantial evidence or clinical experience," the letter said.
The FDA asked that Pfizer immediately stop disseminating the promotional materials and submit a written by July 27. Go to the FDA Web site to read the letter.
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